In what follows, the treatment of mucous tissue and female genital problems are described in more detail but the invention applies also to the treatments of other tissues and body cavities.
Mucosa is the moist tissue that in addition to some human organs lines body cavities. There are a number of health problems that are caused by a deteriorating laxity, elasticity and tightness of mucous membranes and the underlying adjacent tissues (muscles et cetera) The following are some of the most common problems: a) involuntary loss of urine called urinary incontinence (UI) among women; b) loss of anal sphincter control leading to the unwanted or untimely release of feces or gas called anal or fecal incontinence; c) vaginal relaxation and the loss of sexual gratification in women and d) snoring.
Mucous tissue is rich with collagen, a protein which is responsible for the vaginal tissue's elasticity and turgor. Collagen is also the most important component of the muscular tissue's endomysium. The metabolism of collagen degrades with age which leads to deteriorating laxity, elasticity and tightness of mucous membranes and the underlying adjacent tissues (muscles et cetera) The loss of the optimal structure of uterus is not only a consequence of aging, but is also a consequence of injuries during child delivery. Multiple vaginal deliveries and in particular deliveries with the assistance of instruments are additional risk factors for injuries to vagina and pelvic floor. The most common consequence of the above chain of events is urinary incontinence. Clinical studies show that about 30% of women in the reproductive period experience problems with involuntary leakage of urine. However, only approximately 25% of these women decide to seek professional help. Due to the involuntary urine leakage approximately the same percentage of women is also not satisfied with their sexual life. In addition, the vaginal relaxation diminishes the sense of contact during the intercourse, which in turn influences the sexual gratification and quality of life. Other problems related to the degradation of female genital mucous tissues include but are not limited to the vaginal prolapse (pelvic organ prolapse) and atrophic vaginitis (vaginal dryness).
Several approaches have been developed to address the issue of deteriorating body cavity tissues. The most common current technique utilizes a surgical procedure that requires the cutting and rearrangement of the tissue in order to reformat the body cavity. Operating on or near sensitive tissues is inherently risky and can cause scarring, nerve damage and decreased sensation. Furthermore, patients require an extended recovery period.
It is well known that heat pulsing (that is, temporarily increasing the temperature) of collagen can not only improve the collagen structure but also initiate neo-collagenesis, that is, the generation of new collagen. As a result of the temperature increase, the intermolecular cross-links are broken which stabilizes the collagen's triple-helix structure, and leads to the collagen shrinkage. This suggests that heat pulsing of the endopelvic fascia and pelvic floor tissue could represent an effective, non-surgical method for treating female urinary incontinence and vaginal relaxation syndrome. Radio-frequency (RF) devices have been cleared for treating female stress urinary incontinence, elevating temperatures of submucosa around the bladder neck and proximal urethra to about 65° C. However, the treatments with RF devices are deep and invasive, presenting higher risks of adverse effects such as: dysuria, urinary retention, post-op pain and urinary tract infections. Also, since the RF energy is delivered transurethrally, these treatments are painful, and require anaesthesia.
Many experimental and clinical studies up to date have demonstrated the benefits of laser technology for treating conditions and illnesses resulting from damaged collagen. Most of the progress has been made in the area of dermatology and aesthetic medicine. However, from U.S. Pat. No. 8,709,057 an apparatus and method are known, using a laser for treating mucous tissue in body cavities which is based on a non-ablative heat pulsing of the body cavity wall with a laser. According to the above prior art apparatus and method, the laser system comprises a laser source for generating a laser beam, a control unit and a hand piece for manually guiding the laser beam onto a body cavity, such as the vagina wall.
However, there are some significant limitations when applying prior apparatus to treat the interior body cavity wall. The prior art procedure is slow and requires constant attention of the operator. For example, a typical vaginal procedure according to the prior art consists of the following steps: i) a speculum is inserted into the patient's vagina; ii) a laser handpiece adapter with either a flat or angular mirror is inserted into the speculum; iii) with the handpiece adapter fully inserted and the mirror properly oriented, the practitioner starts delivering laser energy per each location; iv) after an appropriate amount of laser energy has been delivered to a certain location, the laser handpiece adapter is manually rotated and/or moved longitudinally within the speculum in order to be able to irradiate a different location on the vaginal wall; v) this procedure is repeated until substantially the whole interior vaginal wall has been irradiated.